Senior Validation Engineer – CQV Expert

Bristol Myers Squibb EU Policy; Bothell (WA); On-site; USD 107,000 - 130,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well‑being

Paid Time Off

Job summary

Bristol Myers Squibb in Bothell, WA seeks a Senior Engineer I, Validation to lead commissioning, qualification and validation (CQV) activities for GMP operations. You will work with cross‑functional teams including Facilities, IT, Manufacturing and QA, ensuring IQ/OQ/PQ deliverables meet regulatory requirements.

The role requires 5+ years CQV experience, strong knowledge of cGMP and CSV, and excellent project management and technical writing skills.

Qualifications

• 5+ years of commissioning, qualification and validation (CQV) experience within technical and regulated industries.
• Robust knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15 and data integrity requirements.
• Experience with equipment, utility and facility qualifications and general commissioning, qualification and validation CQV practices.
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry is beneficial.
• Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (URS to IQ/OQ/PQ and CSV).
• Excellent project and programme management, communication and technical writing skills.
• Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents.
• Possess the professionalism and technical competency to represent the department before customers, regulatory agencies and management.
• Experience in the Pharma / Biopharma required; cell therapy industry is a plus.
• Detail oriented, with strong GMP, validation and engineering experience.
• Experience utilising regulatory knowledge to drive innovation and improvement in validation and engineering functions.

Responsibilities

• Establish validation protocols, risk assessments, and qualification plans to support GMP operations.
• Acts as a validation SME providing support to multi‑function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Executes multiple projects that require qualification work arising from change controls, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders.
• Work collaboratively with peers within the cross‑functional teams to manage workload, address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
• Regularly reviews, prioritises, and promptly responds to customer equipment qualification and support requests.
• Routinely seeks opportunities to learn BMS values and demonstrates them.
• Foster a culture of compliance, quality, and continuous improvement within the validation team.
• Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations remain in full compliance.
• Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes.
• Collaborate with cross‑functional teams to address any findings related to validation and implement corrective actions as necessary.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including analytics, autoclaves and environmental monitoring systems.
• Implement risk‑based validation approaches to optimise processes and reduce validation cycle times while maintaining quality.
• Identify opportunities for process optimisation and efficiency improvements within the validation function.
• Develop and deliver training programmes for validation team members.

Skills

CQV experience

cGMP knowledge

Project management

Technical writing

Quality systems

Education

Bachelor’s Degree in life sciences, engineering, STEM or equivalent years of experience

Tools

CSV (Computer System Validation)

URS/IQ/OQ/PQ lifecycle

Electronic document management systems

Job description

Bristol Myers Squibb in Bothell, WA seeks a Senior Engineer I, Validation to lead commissioning, qualification and validation (CQV) activities for GMP operations. You will work with cross‑functional teams including Facilities, IT, Manufacturing and QA, ensuring IQ/OQ/PQ deliverables meet regulatory requirements.

The role requires 5+ years CQV experience, strong knowledge of cGMP and CSV, and excellent project management and technical writing skills.